Behavioral Activation Therapy for Smoking Cessation

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as
in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study
group is better, the same, or worse than the other group. You will have an equal chance of
being assigned to Group 1 or 2.

- If you are in Group 1, you will receive an active nicotine patch and BATS counseling,
which focuses on helping to increase rewarding experiences while quitting smoking.

- If you are in Group 2, you will receive an active nicotine patch and Health Education/
Smoking Cessation counseling, which focuses on coping strategies for not smoking and
related health issues.

You will not know which group you are assigned to.

Study Drug Administration:

You will start using your nicotine patches on your scheduled quit day, which is about 4 weeks
from the beginning of the study (the day before Visit 4).

You should apply the nicotine patch to the upper arm. You should put it in a slightly
different place each day to avoid skin irritation. You may take the patch off at night to
avoid sleeping problems.

You will be given a study diary to record how many cigarettes you smoke (if any) each day
while you are on study.

You must return your study diary and any unused study patches at Visit 9.

Study Visits (Visits 1-9):

At Visit 1:

- Urine or saliva will be collected for a routine test to check your nicotine, cotinine
and anabasine levels. Cotinine is a chemical released in your body when it breaks down
nicotine and will show whether and how much you have recently smoked. Anabasine is used
to show if nicotine is found in the urine due to a nicotine replacement therapy or from
tobacco use.

- Your CO level and weight will be measured.

- You will also perform tasks related to smoking behavior that will take 45 minutes.

At every study visit:

- You will complete questionnaires about several topics, including depression, suicide,
your smoking behavior, and any side effects from the study patch. These questionnaires
should take about 45-60 minutes in total to complete. Your counselor will not have
access to the computer questionnaires so that your responses will be kept confidential.

- You will receive counseling about quitting smoking, where you will talk about possible
"triggers" for smoking and strategies for dealing with quitting smoking. These sessions
will take about 45 minutes each. These sessions may be audiotaped.

During counseling on Visit 1, you will set a "quit date" for stopping smoking, about 3 weeks
later. You should not quit smoking before the quit date. You may also set goals to reduce
your smoking before that point. You should try to stay smoke-free after the quit date. You
will also be given a drug instruction sheet, a card with emergency contact information, and a
participant manual to help you follow along with the topics discussed during counseling.

You may be asked to complete assignments at home in between visits.

Lab Session:

You will take part in a lab session at or before Visit 1 to test your brain activity. You
will be asked to watch a series of slides. The slides will include pictures of people,
nature, and artwork. Slides showing nude people, medical procedures, and victims of car
crashes will also be shown. You will be shown examples of these slides before beginning the
procedure and given the opportunity to withdraw from the study at that point.

During the lab session, your brain electrical activity will be checked with an
electroencephalogram (EEG). To do this, small sensors will be placed on your scalp and face.
You should not drink more than 2 cups of coffee or other caffeinated drinks for at least 2½
hours before the session. At the lab session, you may be asked to smoke a cigarette if the
doctor thinks it is needed for you to show your normal smoking behavior.

You will also complete computer tasks, including questionnaires that will measure your
emotions and attention level. These tasks should take about 90 minutes to complete.

The lab session may last up to 2 hours total.

Length of Treatment:

You will receive the nicotine patch and counseling for up to 8 weeks. You will be taken off
study early if the study staff thinks it is in your best interest or if you are unable to
follow study directions.

Your participation on the study will be over after the follow-up visits (Visits 9 and 10,
below).

End-of-Treatment Visit (Visit 9):

After you have finished using the nicotine patch, the following tests and procedures will be
performed:

- Your CO level will be measured.

- Urine or saliva may be collected to measure your cotinine and anabasine levels.

- You will complete the same questionnaires you completed at the regular study visits.

Follow-Up Visit (Visit 10):

At about 3 months after you have stopped smoking, the following tests and procedures will be
performed:

- Your CO level will be measured.

- Urine or saliva may be collected to measure your cotinine and anabasine levels.

- You will complete the same questionnaires you completed at the regular study visits.

This is an investigational study. The nicotine patch is FDA approved and commercially
available to help people stop smoking.

Up to 80 participants will be enrolled in this portion of the study. All will take part at MD
Anderson.

Inclusion Criteria:

1. Age: 18-75 years old

2. Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within
the 2 months preceding the screening visit and expired carbon monoxide (CO) greater
than or equal to 6 parts per million (ppm). (if < 6, then NicAlert Strip >2).

3. Interested in treatment that might change smoking behavior

4. Able to follow verbal and written instructions in English and complete all aspects of
the study

5. Provide informed consent and agree to all assessments and study procedures

6. Have an address and telephone number where they may be reached

7. Be the only participant in their household

Exclusion Criteria:

1. Within the month immediately preceding the screening visit, use of any form of tobacco
products other than cigarettes, little cigars or cigarillos on 3 or more days within a
week if the individual refuses to refrain from such tobacco use during the course of
the study.

2. Current enrollment or plans to enroll in another smoking cessation program in the next
6 months

3. Plan to use other nicotine substitutes (i.e., over-the-counter (OTC) or prescription
medication for smoking cessation) or smoking cessation treatments in the next 6 months

4. Uncontrolled hypertension (systolic blood pressure; SBP greater than 180 or diastolic
blood pressure; DBP greater than 110)

5. Reports diagnosis of seizure disorder or a history of neurological illness or closed
head injury that in the opinion of the PI or designated expert(s) feels that it would
affect the results of the EEG.

6. Current use of certain medications: (1) Smoking cessation meds (last 7 days), i.e.,
Wellbutrin, Bupropion, Zyban, NRT, Chantix, (2) Certain medications to treat
depression (last 14 days), i.e. MAOIs and Elavil (Amitriptyline), or (3) Other
medications listed on the Exclusionary Medications list.

7. Meet criteria for the following psychiatric and/or substance use disorders as assessed
by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or
hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 6 months only;
current alcohol dependence), J (substance abuse - Substance Abuse Addendum - past 6
months only; current substance dependence), K (psychotic disorder or mood disorder
with psychotic features). Individuals who meet criteria for non-exclusionary
psychiatric disorders that are considered clinically unstable and/or unsuitable to
participate as determined by the Principal Investigator.

8. Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as
assessed by Module B of the MINI.

9. Psychiatric hospitalization within 1 year of screening date.

10. A positive urine pregnancy test during the screening period. Women who are two years
post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy
will not be subject to a urine pregnancy test.

11. Pregnant, breast-feeding or of childbearing potential and is not protected by a
medically acceptable, effective method of birth control while enrolled in the study.
Medically acceptable contraceptives include: (1) approved hormonal contraceptives
(such as birth control pills, patches, implants or injections), (2) barrier methods
(such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device
(IUD). Contraceptive measures sold for emergency use after unprotected sex are not
acceptable methods for routine use.

12. History of hypersensitivity or allergic reaction to NRT, or any component of its
formulation.

13. Any medical or psychiatric condition, illness, disorder, or concomitant medication
that could compromise participant safety or treatment, as determined by the Principal
Investigator.

14. Subject considered by the investigator as unsuitable candidate for receipt of NRT, or
unstable to be followed up throughout the entire duration of the study.

15. Must not have visual problems that in the investigators opinion would interfere in the
completion of the study assessments

16. Unwilling to change hairstyle or remove a wig as necessary for the appointment to
accommodate the net that is required to be worn on the scalp during the study
procedure.

17. Positive toxicology screen for any of the following drugs: cocaine, opiates,
methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or PCP. A.
Participants with valid prescriptions for opiates, benzodiazepines, barbiturates,
amphetamines or methadone will not be excluded. B. Participants failing the toxicology
screen will be allowed to re-screen once. If they test positive again, they will not
be allowed to return for 90 days.